Full Press Release Details
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update
| Positive Preliminary Topline Data for ATI-450, an Investigational Oral MK2 Inhibitor, in Moderate to Severe Rheumatoid Arthritis Announced in January 2021 | |||
| ATI-450 Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis | |||
| Public Offering of $103.5M in January 2021 Strengthens Balance Sheet |
WAYNE, Pa., February 25, 2021 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year of 2020 and provided a corporate update.
"As we reflect on 2020, we are proud of how we have progressed our immuno-inflammatory development programs," said Dr. Neal Walker, President & CEO of Aclaris. "We are very excited about the platform potential of ATI-450, an oral MK2 inhibitor which we have shown to inhibit TNF , IL1 , and IL6. Given its novel mechanism, there are several immuno-inflammatory indications that ATI-450 may potentially address. We are also excited about the potential of our pipeline which is internally generated from KINect , our proprietary drug discovery platform, for various immuno-inflammatory indications. We look forward to building on this momentum in 2021."
Research and Development Highlights:
The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.
Financial Highlights:
Liquidity and Capital Resources
As of December 31, 2020, Aclaris had aggregate cash, cash equivalents, restricted cash and marketable securities of $54.1 million compared to $75.0 million as of December 31, 2019. The changes in cash and cash equivalents and marketable securities during the year included:
In January 2021, Aclaris closed a public offering in which it sold approximately 6.3 million shares of common stock. Proceeds from the offering were $103.5 million, net of underwriting discounts, commissions and offering expenses. Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2020 in combination with the proceeds from the January 2021 public offering will be sufficient to fund its operations through the end of 2023, without giving effect to any potential business development transactions or financing activities.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "intend," "may," "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials and timing for regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2023. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2020, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC Filings" page of the "Investors" section of Aclaris' website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no
obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Aclaris Therapeutics, Inc.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Revenues: | ||||||||||||
| Contract research | $ | 1,413 | $ | 1,095 | $ | 5,786 | $ | 4,227 | ||||
| Other revenue | 167 | - | 696 | - | ||||||||
| Total revenue | 1,580 | 1,095 | 6,482 | 4,227 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 1,286 | 1,028 | 5,133 | 4,055 | ||||||||
| Research and development (1) | 8,956 | 11,540 | 31,731 | 64,899 | ||||||||
| General and administrative (1) | 4,898 | 5,809 | 20,530 | 27,827 | ||||||||
| Goodwill impairment | - | - | - | 18,504 | ||||||||
| Total costs and expenses | 15,140 | 18,377 | 57,394 | 115,285 | ||||||||
| Loss from operations | (13,560) | (17,282) | (50,912) | (111,058) | ||||||||
| Other expense, net | (219) | (1,895) | (424) | (2,484) | ||||||||
| Loss from continuing operations before income taxes | (13,779) | (19,177) | (51,336) | (113,542) | ||||||||
| Income tax benefit | (182) | - | (182) | - | ||||||||
| Loss from continuing operations | (13,597) | (19,177) | (51,154) | (113,542) | ||||||||
| Income (loss) from discontinued operations, net of tax (1) | 424 | 583 | 139 | (47,812) | ||||||||
| Net loss | $ | (13,173) | $ | (18,594) | $ | (51,015) | $ | (161,354) | ||||
| Net loss per share, basic and diluted | $ | (0.30) | $ | (0.45) | $ | (1.20) | $ | (3.90) | ||||
| Weighted average common shares outstanding, basic and diluted | 43,588,095 | 41,405,657 | 42,539,293 | 41,323,921 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 218 | $ | 249 | $ | 946 | $ | 703 | ||||
| Research and development | 727 | 358 | 2,919 | 5,091 | ||||||||
| General and administrative | 1,559 | 2,581 | 7,342 | 10,288 | ||||||||
| Income (loss) from discontinued operations, net of tax | - | (7) | - | 95 | ||||||||
| Total stock-based compensation expense | $ | 2,504 | $ | 3,181 | $ | 11,207 | $ | 16,177 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| December 31, 2020 | December 31, 2019 | ||||||
| Cash, cash equivalents, restricted cash and marketable securities | $ | 54,131 | $ | 75,015 | |||
| Total assets | 70,784 | 98,297 | |||||
| Total current liabilities | 14,874 | 22,432 | |||||
| Total liabilities | 33,134 | 28,385 | |||||
| Total stockholders' equity | 37,650 | 69,912 |